Accidental FallsBaMPerNCT01439451
Effect of Perturbation Training on Balance Control in Elderly Persons
A study testing perturbation training in people with Accidental Falls, run by Barzilai Medical Center at 2 sites in Israel.
Trial summary
The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- perturbation training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be 70 years or older, male or female
- Be an independent ambulator (not cane or walker) and provide medical waiver from MD.
Who cannot join
- Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty
- Moderate-severe dementia (Mini-Mental Score < 24).
- Serious visual impairment
- Severe peripheral or compression/entrapment neuropathies.
- Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.
- Cancer, metastatic or under active treatment.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Ben-Gurion University of the Negev
Beersheba, 84105
Beit Yona
Beersheba
About this study
Official title: Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial
The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training.
Read the detailed description
A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period.
- Conditions
- Accidental Falls
- Being tested
- perturbation training
- Keywords
- Balance control, Aging, Balance reactions, Perturbation, above seventy years old
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perturbation trainingProcedure or surgery
Also called treadmill walking, perturbation training during walking
The experimental and control groups will participate in 3 month training program twice a week 20 minutes each training session
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | perturbation training during walking Receives: Procedure: perturbation training |
| controls | Active comparator | treadmill walking Receives: Procedure: perturbation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
voluntary and compensatory step execution times in miliseconds
the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds
Measured: change from baseline to 3 months later
Secondary outcomes (1)
postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres
body sway will be measured to evaluate control of posture
Measured: Time 1: pre test' and 3 months later time 2: post testing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ornit Cohen, Barzilai Medical Center
- Investigators
- Ronen Debi, MD, Study chair, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439451
- Sponsor's protocol ID
- BARZI1729
- Acronym
- BaMPer
- Status last verified
- Aug 2015
- First submitted
- 11 Sep 2011
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Batcir S, Gimmon Y, Kurz I, Edelman S, Levitsky Gil N, Adar R, Rabaev E, Debi R, Shani G, Shapiro A, Melzer I. Effect of Surface Perturbation Treadmill Training Program on Strategies and Kinematics of Reactive Stepping during Standing in Older Adults: A Single-Blinded Randomized Controlled Trial. Gerontology. 2025;71(6):439-452. doi: 10.1159/000545480. Epub 2025 Mar 28.
PubMed 40359925Batcir S, Shani G, Shapiro A, Alexander N, Melzer I. The kinematics and strategies of recovery steps during lateral losses of balance in standing at different perturbation magnitudes in older adults with varying history of falls. BMC Geriatr. 2020 Jul 20;20(1):249. doi: 10.1186/s12877-020-01650-4.
PubMed 32689965Nachmani H, Shani G, Shapiro A, Melzer I. Characteristics of First Recovery Step Response following Unexpected Loss of Balance during Walking: A Dynamic Approach. Gerontology. 2020;66(4):362-370. doi: 10.1159/000505649. Epub 2020 Feb 18.
PubMed 32069450Kurz I, Gimmon Y, Shapiro A, Debi R, Snir Y, Melzer I. Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial. BMC Geriatr. 2016 Mar 4;16:58. doi: 10.1186/s12877-016-0223-4.
PubMed 26944706
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balance Perturbation to Improve Gait and Balance Control and Prevent Falls in Elderly Persons -A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01439451
- Acronym / sponsor ID
- BaMPer / BARZI1729
- Conditions
- Accidental Falls
- Keywords
- Balance control, Aging, Balance reactions, Perturbation, above seventy years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project is a prospective experimental Randomized Control Trial study design. Independent old adults (age 70 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after Peturbation balance training during walking to explore whether there are differences in balance control and balance reactions as a result of training.
Detailed description
A total of 48 old adults will be enrolled, evaluated and trained. They will be randomly assigned to two groups: one exercise group (perturbation training) and one group without perturbation. No gender based differences are expected for the recovery outcome measures so we will be able to pool male and female individuals for this analysis. Each subject of the experimental and of the control groups will be trained on 24 occasions over a period of 10-12 weeks (20-30 minutes, 2-3 times/week). This regimen was based on previous balance training study that demonstrated improvements in balance control with similar training duration and frequency. Gait and balance function and physical activity level will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit and carryover of training. In addition using monthly phone calls, falls, their severity, functional activity limitations in the home and community setting and health status will be monitored 12 months after the training period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Procedure: perturbation trainingperturbation training during walking |
| controls | Active comparator | Procedure: perturbation trainingtreadmill walking |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Be 70 years or older, male or female
- Be an independent ambulator (not cane or walker) and provide medical waiver from MD.
Key exclusion criteria (6 listed)
- Severe focal muscle weakness or paralysis, after Total Hip or knee arthroplasty
- Moderate-severe dementia (Mini-Mental Score < 24).
- Serious visual impairment
- Severe peripheral or compression/entrapment neuropathies.
- Symptomatic orthostatic hypotension, respiratory, cardiovascular, musculoskeletal, or neurological disorders that may interfere with participation in the exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perturbation trainingAlso: treadmill walking, perturbation training during walkingThe experimental and control groups will participate in 3 month training program twice a week 20 minutes each training session | Procedure or surgery | controls, experimental |
Primary outcome
voluntary and compensatory step execution times in miliseconds
Time frame: change from baseline to 3 months later
the time from perturbation to foot contact the floor completing the recovary stepping will be measured in miliseconds
1 secondary outcome
postural sway parameters such as mediolateral sway in milimeters and elliptical area in milimeters squeres
Time frame: Time 1: pre test' and 3 months later time 2: post testing procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Derived from this study: PubMed 40359925Batcir S, Gimmon Y, Kurz I, Edelman S, Levitsky Gil N, Adar R, Rabaev E, Debi R, Shani G, Shapiro A, Melzer I. Effect of Surface Perturbation Treadmill Training Program on Strategies and Kinematics of Reactive Stepping during Standing in Older Adults: A Single-Blinded Randomized Controlled Trial. Gerontology. 2025;71(6):439-452. doi: 10.1159/000545480. Epub 2025 Mar 28.
- Derived from this study: PubMed 32689965Batcir S, Shani G, Shapiro A, Alexander N, Melzer I. The kinematics and strategies of recovery steps during lateral losses of balance in standing at different perturbation magnitudes in older adults with varying history of falls. BMC Geriatr. 2020 Jul 20;20(1):249. doi: 10.1186/s12877-020-01650-4.
- Derived from this study: PubMed 32069450Nachmani H, Shani G, Shapiro A, Melzer I. Characteristics of First Recovery Step Response following Unexpected Loss of Balance during Walking: A Dynamic Approach. Gerontology. 2020;66(4):362-370. doi: 10.1159/000505649. Epub 2020 Feb 18.
- Derived from this study: PubMed 26944706Kurz I, Gimmon Y, Shapiro A, Debi R, Snir Y, Melzer I. Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial. BMC Geriatr. 2016 Mar 4;16:58. doi: 10.1186/s12877-016-0223-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronen Debi, MD study chair
Barzilai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perturbation training in people with Accidental Falls, run by Barzilai Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
voluntary and compensatory step execution times in miliseconds (time frame: change from baseline to 3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01439451, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.